A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 341
- 主要终点
- Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay
研究概览
简要总结
This study will evaluate the safety and immunogenicity of a heat-treated VZV vaccine in autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants with a baseline cluster of differentiation 4 (CD4) cell count ≤200 cells/mm^3, participants with solid tumor malignancy (STM; breast, colorectal, lung, or ovarian malignancies) receiving chemotherapy, and participants with hematologic malignancy (HM; leukemia or leukemia-like disease, lymphoma or lymphoma-like disease, or multiple myeloma). The primary hypothesis is that the heat-treated VZV vaccine will elicit significant VZV-specific immune responses measured by either glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) or VZV gamma interferon enzyme-linked immunospot (IFN-ELISPOT) at 28 days post dose vaccination 4 in, HIV-infected participants, participants with STM, and participants with HM. The primary immunogenicity objective and endpoints were considered by the protocol as exploratory for the autologous and allogeneic HCT groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women > or = to 18 years of age who are scheduled to receive an autologous or allogeneic hematopoietic cell transplant within 60 days of enrollment
- •HIV-infected participants with a baseline CD4 cell count < or = to 200 cells/mm^3
- •Participants with hematologic malignancies; or participants who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies
排除标准
- •History of allergy to any vaccine component
- •Prior history of HZ
- •Prior history of receipt of any varicella or zoster vaccine
结局指标
主要结局
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay
时间窗: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
时间窗: up to 28 days post vaccination 4 (up to ~Day 118)
An SAE was defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants that experienced at least 1 SAE was summarized.
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)
时间窗: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
次要结局
- Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC)(Up to Day 5 post any vaccination)
- Percentage of Participants With a Systemic Adverse Event Prompted on the VRC(Up to 28 days post vaccination 4 (up to ~118 days))
- Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC(Up to 28 days post any vaccination (up to ~118 days))